Viewing data from:

MACITENTAN

ANDA

MACITENTAN | A211000 | AMNEAL EU LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: OPSUMIT(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ACTELION PHARMACEUTICALS LTD v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2018cv01397 1 patentANDA 211224, 211000macitentan	D.N.J.	2018-01-31	Terminated 2020-09-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain14 active DMFs

14 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDMACITENTAN [ROUTE CODE IM]

DMF 302122016

MATRIX PHARMACORP PRIVATE LTDMACITENTAN

DMF 309692016

RAKS PHARMA PVT LTDMACITENTAN

DMF 311792016

HONOUR LAB LTDMACITENTAN

DMF 312132017

TAPI NL BVMACITENTAN

DMF 314162017

ZYDUS LIFESCIENCES LTDMACITENTAN

DMF 314632017

SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTDMACITENTAN

DMF 316582017

ALEMBIC PHARMACEUTICALS LTDMACITENTAN

DMF 316642017

APITORIA PHARMA PRIVATE LTDMACITENTAN

DMF 317492017

LAURUS LABS LTDMACITENTAN

DMF 319572017

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDMACITENTAN

DMF 392732023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDMACITENTAN

DMF 392882024

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDMACITENTAN

DMF 411522025

ZHEJIANG XIANFENG TECHNOLOGY GROUP CO LTDMACITENTAN

DMF 414442025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	ORIG -1	View Letter (PDF)
Mar 19, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 8, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Amneal Pharmaceuticals received FDA approval for Macitentan (NDA 211000, strength 001).

New: New record